The following data is part of a premarket notification filed by Igc-medical Advances, Inc. with the FDA for Torso Array Coil, Model 558ge-64.
| Device ID | K041185 |
| 510k Number | K041185 |
| Device Name: | TORSO ARRAY COIL, MODEL 558GE-64 |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | IGC-MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226 |
| Contact | Anthony Dietzler |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-05-06 |
| Decision Date | 2004-05-14 |
| Summary: | summary |